Tag Archives: World Health Organization

Just when it seemed like consensus existed on how to handle the hot potato of mammalian-transmissible H5N1 influenza, the public release on Friday afternoon of a letter sent April 12 from the respected influenza and public health researcher Dr. Michael Osterholm to a National Institutes of Health official collapsed the apparent consensus like a house of cards.

To recap: On March 29 and 30, the U.S. government’s National Science Advisory Board for Biosafety (NSABB), organized by the NIH’s Office of Science Policy, met to reconsider the NSABB’s original decision last December that said the paper written by Dr. Yoshihiro Kawaoka and another paper by Dr. Ron Fouchier on their respective efforts to produce and study H5N1 mutants transmissible by air from ferret to ferret should only be published without the methods sections, a way to prevent release of the details on how they developed these potentially dangerous mutant strains. The initial NSABB recommendation to allow publication of only the redacted papers failed to win support from a panel convened by the World Health Organization in February, creating a conflict between the NSABB (and hence the NIH) and the WHO. Claiming that new data first revealed to the WHO group led to the different outcome, Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases — the U.S. agency that sponsored the work of both Dr. Kawaoka and Dr. Fouchier — called on the NSABB to rethink its initial decision, which resulted in the NSABB reversing itself on March 30 and supporting full publication, in a unanimous vote for Dr. Kawaoka’s work, and in a 12-6 vote for Dr. Fouchier’s. So, by early April, the NSABB (and hence, pending official U.S. policy) and the WHO agreed that full H5N1 publication could proceed. Peace reigned across the land.

Dr. Michael Osterholm

Until 2 weeks later, when Dr. Osterholm an NSABB member, upset the tranquility by writing his bombshell letter to Dr. Amy Patterson, NIH’s associate director for Science Policy. In it, Dr. Osterholm took vigorous swipes at how the NIH set up the NSABB’s reconsideration session and detailed his grave concerns about public release of how the H5N1 work was done. Both “Science” and “Nature” received the letter on April 13, and according to a report in “Nature,” Dr. Osterholm said he was not the source for the leak.

“I believe the agenda and speakers for the March 29 and 30 NSABB meeting as determined by the Office of Biotechnology Activities [part of the NIH’s Office of Science Policy] staff and other U.S. government officials was designed to produce the outcome that occurred,” Dr. Osterholm charged in his letter. “It represented a very ‘one-sided’ picture of the risk-benefit of the dissemination of the information in these manuscripts. The agenda was not designed to promote a balanced reconsideration of the manuscripts.”

A major problem, he said, was that the “experts that addressed [the March NSABB session] have a real conflict of interest in that their laboratories are involved in this same type of work and the results of our deliberations directly affect them too.” The same problem occurred at the WHO meeting in February, he added.

Dr. Osterholm tempered his charge by saying he did not “suggest that there was a sinister motive by the U.S. government,” but still leveled a hefty blast, saying “I believe there was a bias toward finding a solution that was a lot less about robust science- and policy-based risk-benefit and more about how to get us out of this difficult situation.”

The upshot was that in the revised decision NSABB, U.S. policy makers, and researchers failed to “come to grips with the very difficult task of managing dual-use research of concern and the dissemination of potentially harmful information to those who might intentionally or unintentionally use that information in a harmful way.” His worry is — if not in this case — “will the Board ever find a bright line for redacting publication” of any future research that could potentially threaten public health?

Dr. Osterholm cited a major danger if details of this research became fully public: “A ferret-to-ferret experiment is expensive and technically demanding, and could only be done by a handful of labs in the world. Once the mutations are public, individuals … in many other labs could generate the mutants in a few weeks given several thousand dollars for gene synthesis,” using reverse genetics.

Finally, Dr. Osterholm questioned the public-health benefit from full release of the methods sections of the two H5N1 papers. “The most important aspect of the results in these two studies on surveillance and control has already been accomplished namely alerting the world to the possibility that H5N1 influenza virus surely can become a mammalian-transmitted virus and poses real pandemic potential.” Publication of more details from the research will not add to that alert, nor would it immediately help in the development or production of countermeasures against a potential H5N1 pandemic, he said.

Despite his concerns over full disclosure of the methods, Dr. Osterholm affirmed his overall support for this H5N1 research in a comment to “Nature” on Friday. “I have been and continue to be a supporter of this kind of research,” he told the journal.

Dr. Ron Fouchier, one of the two researchers who developed and studied mutant forms of avian H5N1 influenza that’s transmissible through the air, provided new details of his findings at a conference this morning in Washington. He explained that the mutant virus is not nearly as deadly or transmissible as many people have supposed.

This new information seems to be, at least in part, at the root of the different conclusions recently reached by the U.S. National Science Advisory Board for Biosecurity (NSABB) and by a group organized by the World Health Organization (WHO) on whether detailed methods of the H5N1 mutant research should be released to the public. During the past few days, the National Institutes of Health called on the NSABB to meet again to hear the new data and see if it would change the Board’s decision to keep the methods sections of the papers under wraps, Dr. Anthony Fauci said at today’s meeting.

ferret; courtesy hemmer@fr.wikipedia, Wikimedia Commons

“This virus does not kill ferrets that are sneezed on [by ferrets already infected with mutant H5N1], and if it was released it is unlikely that it would spread like wildfire, and to extrapolate that it would spread like wildfire in humans is really farfetched at this stage,” said Dr. Fouchier, a researcher at Erasmus University in Rotterdam. “This virus does not spread like a pandemic or seasonal influenza virus,” he said in a session that dealt with H5N1 issues during a meeting on Biodefense and Emerging Diseases sponsored by the American Society for Microbiology. He called any notion that the mutant avian H5N1 flu he created could transmit readily in aerosolized form from ferret-to-ferret a “misperception.”

In addition, many people have had a second important misperception of the virus he’s studied: The H5N1 mutant strains he created are not highly lethal.

“It’s very clear that H5N1 is highly lethal in chickens, but in mammals that’s not the case.” The mutant form of the virus will kill a ferret if you place a large dose of the virus—a million virions—directly into the animals lower respiratory tract. That kills the animal in about 3 days, he said. But if a more modest and typical inoculum gets introduced intranasally to a ferret, the animal simply gets a flu-like illness but recovers. “We saw no severe disease in any of the seven animals that received virus by aerosol,” he said.

A third, heartening observation he’s made about how mammalian-transmissible H5N1 behaves is that ferrets exposed to seasonal flu before exposure to the H5N1 mutant “are fully protected against severe disease.” His conclusion from this: “It’s unlikely that humans have no cross protection to H5N1, so very few would develop severe disease. Most [people] would be protected by cross-protective immunity.”

According to Dr. Fauci, director of the National Institute of Allergy and Infectious Disease, these clarifications from Dr. Fouchier first came to light earlier this month during a meeting on H5N1 convened by the WHO in Geneva. These new data, as well as the recommendations made by the WHO group, led Dr. Fauci to ask the NSABB to reconvene.

“The NIH continues to support the NSABB recommendations regarding the original manuscripts [to publish redacted versions of the papers], and supports revision of the manuscripts to include new data and explicit clarifications of old data,” Dr. Fauci said. “There was obviously a disagreement in the recommendations between Geneva and the NSABB. There was a strong feeling to reconvene the NSABB to give them the benefit of the same information and discussion as in Geneva.”

The American plan for dealing with public release of details from the H5N1 influenza research funded by the U.S. government got trumped last Friday by the contrary conclusion of a committee assembled by the World Health Organization.

The WHO assembled a group of 22 researchers and policy makers from 10 countries in Geneva on Feb. 16-17 to discuss H5N1 airborne-transmissibility research, and the group came to three main conclusions, according to a statement they released and comments later in a press conference by Dr. Keiji Fukuda, the WHO’s assistant director general for Health Security and the Environment:

■ Research into H5N1 virus capable of airborne transmission from mammal to mammal is important and should continue.

■ Full public reporting of all details of the research done so far by Dr. Fouchier in Rotterdam and Dr. Kawaoka in Madison, Wis., should occur in the near future.

■ Until WHO crafts a process by which these full reports can be released publicly, they should remain under wraps along with continuation of the self-imposed moratorium on further research on the new H5N1 strains previously pledged by both Dr. Fouchier and Dr. Kawaoka.

The WHO panel’s decision directly refutes the ruling first made public last December by the U.S. National Science Advisory Board for Biosecurity (NSABB) to redact the methods sections when the papers by Dr. Fouchier and Dr. Kawaoka are published. Science magazine has been holding the Fouchier manuscript, while Nature has the Kawaoka paper, and until late last week both journals intended to publish the redacted versions of their articles in March. Those plans are now on hold.

While the WHO’s Dr. Fukuda repeatedly stressed that consensus had been reached by the panel, news reports with comments from the two U.S. panelists, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, and Dr. Paul Keim, acting NSABB chairman, suggest something else: Their views got buried.

“I stand by the NSABB recommendations,” said Dr. Fauci, according to a report in Science. During the press conference, Dr. Fukuda admitted that “the representative from NIH pointed out that himself and others from the U.S. on record comply and understand and support the NSABB decision.”

Dr. Keim was blunter in his critique: “I was disappointed in this conclusion [by the WHO panel] as it was one that NSABB worked hard to achieve,” he told Science.

Dr. Bruce Alberts, editor-in-chief of Science, noted in a separate press conference last Friday that the issue had grown too global to be settled by a U.S.-centric group like the NSABB.

“In the long run, an international organization like WHO had to take charge of this… It may be the start of an international version of the NSABB,” Dr. Alberts said.

Dubbed the “anti-noise queen” for her turn-of-the-century crusade against “preventable” noises such as the night-time whistles of tugboats traversing the Hudson near her New York City home, Dr. Rice (1859-1929) also campaigned tirelessly for the promotion of quiet zones near hospitals, decrying the too-loud and too-frequent environmental noises as murderers of sleep and menaces to health.

Fast-forward 100 years, and it appears that researchers at the University of Chicago have proven her point.

In an effort to confirm previous observations that noisy hospital rooms keep inpatients from getting quality sleep, medical student Jordan C. Yoder and colleagues, under the direction of Dr. Vineet M. Arora of the Sleep, Metabolism, and Health Center at the University of Chicago, sought to objectively measure noise and sleep duration in ambulatory adult hospital patients at the university’s medical center. Toward this end, they collected sleep and/or sound data from 106 consenting patients between April 2010 and May 2011, excluding individuals with known sleep disorders, those with cognitive impairment, and those under respiratory isolation or who had been admitted for more than 72 hours (Arch. Intern. Med. 2012 Jan. 9 [172]:68-9).

They found that patient room noise levels were significantly higher than the World Health Organization’s (WHO) recommendations for average noise levels. Further, peak noise level “approached that of a chain saw,” according to their research letter. Nighttime sound levels were lower than daytime levels, but all still significantly exceeded recommendations for maximum noise level and 94% exceeded recommendations for average noise level.

More than 40% of the patients reported noise disruptions of sleep, which were associated with higher maximum noise levels.

Sleep actigraphy data demonstrated that ”patients slept significantly less in the hospital than their self reported baseline sleep,” the authors observed, and mean sleep efficiency when hospitalized was low, with more than half of the recorded nights measuring below the normal lower boundary of 80% efficiency for adults.

While roommates, alarms, intercoms, and pagers were all associated with substantial percentages of noise disruption, the most disruptive source of environmental noise, it appears, was chatty staffers, as the percentage of noise disruption attributed to staff conversation was 65%.

Dr. Arora noted that “some amount of sleep loss in the hospital may be expected given the unfamiliar environment.” In fact, she said in an interview, “our next studies are actually looking at this and the component that may be driven by loss of control or stress.” In the current study, however, “patients lost more sleep in the hospital when noise levels were loudest after accounting for baseline sleep characteristics, so at least noise seems like an independent predictor of hospital sleep, highlighting the importance of optimizing the hospital environment.” The magnitude of the difference, she explained, is one hour less sleep, “which is pretty significant,” Further, patients in noisier rooms reported more complaints of noise, indicating that noise is an issue, she said.

Based on their findings, the authors concluded that “hospitals should implement interventions to reduce nighttime noise levels in an effort to improve patient sleep.” One possibility, Dr. Arora suggested, is a device called a Yacker Tracker, which measures noise and provides feedback to the staff about when the noise level exceeds a certain threshold.

And now that patient report of noise is now a reported measure on Medicare’s Hospital Compare, it will be in the best interest of hospitals as well as patients to implement noise-reduction measures, Dr. Arora noted. “Noisy hospitals will want to optimize patient noise to provide the best experience possible,” she stressed.

The Society for the Suppression of Unnecessary Noise, and its founder, would be well pleased.

Like the unstoppable tide of aging Baby Boomers and the worldwide flood of obesity-related problems, the burden of diabetes is expected to hit tsunami proportions. The number of people with diabetes hasn’t crested yet, but there already may be more people “under water” than expected.

Photo by Sherry Boschert

While the World Health Organization suggests that more than 220 million people around the world have diabetes, and one study estimated 285 million people had diabetes in 2010, a more recent analysis calculated that 347 million people worldwide have diabetes, investigators reported in The Lancet. That’s more than double the 153 million cases worldwide 3 decades ago.

Type 2 diabetes typically begins in middle age, so aging populations play a role, as do rising rates of obesity, a major risk factor for the disease. Using the World Health Organization’s more conservative numbers, an estimated 3.4 million people died in 2004 from problems related to diabetes, 80% of them in low-income and middle-income countries.

It’s no wonder that I heard languages from all over the world being spoken at the American Diabetes Association (ADA) annual scientific meeting. The 17,600 attendees were invited to place push-pins on a world map to show where they’d come from. Some did, providing a snapshot of the international participation in the meeting.

Photo by Sherry Boschert

Affluent countries whose physicians can more easily afford international travel to the meeting are more heavily represented, but the map still gives the impression of one world fighting a common disease. The keys to preventing or slowing diabetes are known and well shared — don’t smoke, eat a healthy diet, be physically active regularly (like 30 minutes of brisk walking 5 days per week), and maintain a normal body weight. If there’s one solution to this one-world problem, it may lie in finding a way for people of all nations to follow that advice.

Easier said than done. But as a major study presented at the meeting calculated, treating people at high risk for diabetes in the United States by either enrolling them in a lifestyle intervention program (to change eating and exercise habits) or by prescribing the drug metformin was extremely cost-effective compared with doing nothing.

Teaching people to “swim,” as it were, or throwing them a pharmaceutical life jacket, may be cheaper and better than expecting them to surf a tsunami.

Before last week, I thought I knew the definition of “noncommunicable disease.” Then I attended “The Long Tail of Global Health Equity: Tackling the Endemic Non-Communicable Diseases of the Bottom Billion.”

Held on the campus of Harvard Medical School in Boston March 2nd and 3rd, the 2-day conference was sponsored by Partners In Health, an international nonprofit organization that conducts research, does advocacy, and provides direct health care services for people living in poverty around the world. The “Bottom Billion” of the meeting’s title refers to the world’s poorest people living on less than $1 per day.

In a 2008-2013 action plan, the World Health Organization refers to “the four noncommunicable diseases – cardiovascular diseases, diabetes, cancers and chronic respiratory diseases and the four shared risk factors – tobacco use, physical inactivity, unhealthy diets and the harmful use of alcohol.” Together, these conditions account for approximately 60% of all global deaths, of which 80% occur in low- and middle-income countries.

A cancer patient in Rwanda receives chemotherapy as her husband and physician discuss her treatment / Photo courtesy of Partners In Health

And most startling to me: Among the world’s poorest, smoking is not the most common cause of chronic obstructive pulmonary disease. Cooking with biomass fuels is.

Individually, these and other so-called “endemic NCDs” including Burkitt’s lymphoma, sickle cell disease, and tropical diseases are far less common than those within the WHO’s “four-by-four” definition. But together, that “long tail” of chronic conditions contributes to a great deal of suffering.

In May 2010, the United Nations announced that it would hold a high-level meeting on NCDs in 2011, now set for September 19-20. It will be only the 29th such meeting that the UN has ever held (formerly called “special sessions“), and just the second pertaining specifically to a health issue. The first one, the 2001 Summit on HIV/AIDS, is credited with focusing global attention and obtaining public and private funding for that cause.

Speakers at the Partners In Health meeting stressed that the NCD movement should not be undertaken as an “us against them” competition with infectious disease for scarce resources. In a statement that will be presented to the heads of government at the UN summit, the group called instead for “strengthening and adjusting health systems to address the prevention, treatment, and care of NCDs, particularly at the primary health care level.”

Leaders in the noncommunicable disease community often state that international donor spending on chronic conditions such as heart disease, diabetes, and cancer far underrepresents their burden in developing countries. Now, a new report from the nonprofit Center for Global Development provides stark data to back up the claim.

Photo by Lawrence OP via Flickr Creative Commons

“Where Have all the Donors Gone? Scarce Donor Funding for Non-Communicable Diseases” examines the trends in public and private donor resources from 2004 to the present. The work was supported by PepsiCo.

Contrary to widespread belief, the impact of chronic, noncommunicable diseases (NCDs) exceeds that of infectious/communicable disease in the developing world as well as the developed. In 2008, NCDs contributed 48% to morbidity and mortality in developing countries, compared with 39% from infectious diseases (with the remainder due to injury). For mortality, those proportions were 59% vs. 31%, according to World Health Organization (WHO) data quoted in the report.

At a panel event held at the CGD’s headquarters in Washington last week, report coauthor Rachel A. Nugent, Ph.D., said $503 million was spent on NCDs in 2007, accounting for less than 3% of the $22 billion in total development assistance for health. In contrast, nearly a third of the total — $6.3 billion — was devoted to HIV, tuberculosis, and malaria.

By disease burden, this works out to less than one U.S. dollar – just 78 cents – per disability-adjusted life year (DALY), compared with $23.9/DALY for the three infectious diseases. “That’s fairly staggering. … It’s a significant disparity in level of effort,” Dr. Nugent commented.

Approximately 15% of health funding in low-income countries comes from external donor sources. The WHO contributed the greatest amount in 2007, $812 million. Other top donors include the Wellcome Trust UK, the World Bank, the Bloomberg Family Foundation, and the Gates Foundation.

Funding for noncommunicable disease will be the focus of a high-level United Nations NCD Summit scheduled for September 2011. The idea is not to take away money from infectious disease, Dr. Nugent said.

Rather, “I hope that growing attention to this issue stays focused on achieving greater health for the money that’s being invested already and additional money that may eventually be invested to increase flexibility in health delivery across sectors and across health conditions, because I think that’s where we’re going to get the most bang for the buck and the best development results.”

Dr. Rachel Nugent and Dr. Derek Yach / Photo by Miriam E. Tucker

And why is PepsiCo interested in this? I asked the company’s senior vice president for global health policy Dr. Derek Yach, who also spoke at the CGD event. His reply: “We are committed to addressing major nutritional and other underlying causes of ill health and NCDs as part of a broad commitment to health and the environment. It is in our long term interests and represents a convergence between opportunities for PepsiCo to build a profitable business based on healthy products.”